Tomtec Imaging Systems GmbH - FDA 510(k) Cleared Devices
21
Total
21
Cleared
0
Denied
Tomtec Imaging Systems GmbH has 21 FDA 510(k) cleared radiology devices. Based in Unterschleissheim, DE.
Last cleared in 2022. Active since 1999.
Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by Tomtec Imaging Systems GmbH
21 devices
Cleared
Jan 06, 2022
TOMTEC-ARENA
Radiology
59d
Cleared
Aug 14, 2020
TOMTEC-ARENA
Radiology
59d
Cleared
Feb 13, 2015
TOMTEC-ARENA TTA2
Radiology
24d
Cleared
Nov 25, 2013
TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA
Radiology
104d
Cleared
Oct 24, 2012
IMAGE-COM 5.0
Radiology
86d
Cleared
Apr 13, 2012
2D CARDIAC PERFORMANCE ANALYSIS MR 1.0
Radiology
87d
Cleared
May 24, 2011
4D LV-ANALYSIS 3.0
Radiology
68d
Cleared
Apr 08, 2011
IMAGE-ARENA AND IMAGE-ARENA APPLICATIONS
Radiology
30d
Cleared
Apr 07, 2011
4D SONO-SCAN 1.0
Radiology
36d
Cleared
Jan 27, 2011
4D MV-ASSESSMENT 2.0
Cardiovascular
31d
Cleared
May 22, 2009
IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0
Radiology
88d
Cleared
Dec 23, 2008
IMAGE-ARENA APPLICATIONS
Radiology
40d